What the next generation of COVID-19 vaccines could look like – WXYZ

What the next generation of COVID-19 vaccines could look like – WXYZ

Coronavirus Roundup: There’s No New Mask Guidance Yet from the CDC – GovExec.com

Coronavirus Roundup: There’s No New Mask Guidance Yet from the CDC – GovExec.com

February 11, 2022

The Homeland Security Department issued a new National Terrorism Advisory Bulletin earlier this week, which has pandemic-related warnings.

As COVID-19 restrictions continue to decrease nationwide, increased access to commercial and government facilities and the rising number of mass gatherings could provide increased opportunities for individuals looking to commit acts of violence to do so, often with little or no warning, said the bulletin. Meanwhile, COVID-19 mitigation measuresparticularly COVID-19 vaccine and mask mandateshave been used by domestic violent extremists to justify violence since 2020 and could continue to inspire these extremists to target government, healthcare and academic institutions that they associate with those measures. The bulletin runs through June 7. Here are some of the other recent headlines you might have missed.

Dr. Raj Panjabi, who most recently led the Presidents Malaria Initiative at the U.S. Agency for International Development, will become the new senior director for global health security and biodefense at the National Security Council, replacing Dr. Beth Cameron. Cameron joined the Biden administration to help re-establish the Directorate for Global Health Security and Biodefense, which former Trump national security adviser John Bolton had folded into another office as part of an effort to streamline the NSC, Axios reported on Tuesday. Cameron played an early role in shaping White House policy for what President Biden had deemed his No. 1 priority on the campaign trail: defeating the pandemic

A new report from the Government Accountability Office looks at the Centers for Disease Control and Prevention, Health Resources and Services Administration, and the Federal Emergency Management Agencys efforts to provide vaccinations to underserved and historically marginalized racial and ethnic groups that were launched in February 2021. Although the available data was limited, our analysis suggests that while the programs vaccinated a greater share of some racial and ethnic groups compared to their shares of the population, disparities exist for other racial and ethnic groups, such as non-Hispanic Black persons, said the report. However, according to [the] CDC, some groups may have a higher likelihood of having missing race and ethnicity data, and the percentage of unknown race and ethnicity data may account for some, or even all, of the differences observed in comparing vaccinations among various racial and ethnic groups to their shares of the U.S. population.

Brian Miller, special inspector general for pandemic recovery, and Jean Saint-Elin, deputy assistant inspector general for auditing, spoke with Social Science Space in a recent interview about how his office looks for and investigates fraud in certain COVID-19 relief programs. We didnt want to wait for hotline complaints, where you wait for insiders to come forward, since with a five-year charter, we couldnt wait to do that, said Miller when asked how he goes about investigations. From the start, we were actively looking at data points, getting data. One of the first agreements I had that we reported in our 60-day report and then in our initial quarterly reports, was our agreements with other law enforcement agencies and we get information that way through agreements, so we can get data to see if people are defrauding the system.

Dr. Rochelle Walensky, CDC director, said during the COVD-19 briefing on Wednesday her agency is working on updated mask guidance for states, but hospitalizations and death rates are still high, so, as we work towards that and as we are encouraged by the current trends, we are not there yet. Many Democratic states have begun to roll back their mask mandates, which has caused some confusion.

A reporter asked during the briefingif people should be listening to their governors or the CDC. We've always said that these decisions are going to have to be made at the local level and that policies at the local level will look at local cases, theyll look at how local hospitals are doing, theyll look at local vaccination rates, Walensky said. And they, as I understand it, in many of these decisions are using a phased approach. Not all of these decisions are being made to stop things tomorrow, but they're looking at a phased approach. While reiterating this has to be done locally, she added: Im really encouraged that cases are continuing to drop dramatically, hospitalizations are continuing to drop dramatically as people are making these decisions and as we are working on our guidance.

On vaccines for children under age five, Jeff Zients, White House coronavirus response coordinator, said during the briefing operationally, we will be ready once [the Food and Drug Administration] and CDC make their recommendations. Since the vaccine is made specifically for young kids we're launching a new program specially for kids under five, he continued. We've secured enough vaccine supply for all kids in this age groupall 18 million.

On Thursday morning, Senate Majority Leader Chuck Schumer, D-N.Y., filed cloture on Bidens nominee to lead the FDA. This nomination has been snared by political controversies on both the left and right, the Associated Press reported. A permanent FDA chief cant come soon enough for the beleaguered agency, which has been straining for months under an intense pandemic workload even as several scientific disputes have battered its reputation.

The Internal Revenue Service announced on Wednesday it will be suspending over a dozen additional letters it normally sends to taxpayers who owe additional taxes or for whom the IRS has no record of a return. This comes as the agency is working through its backlog of unprocessed returns due to the pandemic, a process that has received much scrutiny by lawmakers and other groups. IRS employees are committed to doing everything possible with our limited resources to help people during this period, said IRS Commissioner Chuck Rettig. Our efforts are not limited to suspension of these additional letters and the possibility of similar actions going forward. We have redeployed and reallocated resources throughout the IRS and have implemented innovative strategies in an ongoing effort to provide a meaningful reduction in our inventories.

Help us understand the situation better. Are you a federal employee, contractor or military member with information, concerns, etc. about how your agency is handling the coronavirus? Email us at newstips@govexec.com.


Visit link: Coronavirus Roundup: There's No New Mask Guidance Yet from the CDC - GovExec.com
From obscurity to a Nobel Prize nomination: Houston scientists acclaimed for their patent-free COVID-19 vaccine – The Texas Tribune

From obscurity to a Nobel Prize nomination: Houston scientists acclaimed for their patent-free COVID-19 vaccine – The Texas Tribune

February 11, 2022

Sign up for The Brief, our daily newsletter that keeps readers up to speed on the most essential Texas news

Two years ago, when a pair of Houston scientists first began crafting a cheap, easy-to-make COVID-19 vaccine, they had a tough time finding support for it at home in the U.S., a country that rewards expensive, flashy new tech.

They could have used help with their goal of combating the virus both locally and abroad, where it was morphing into more dangerous variants headed for U.S. shores.

But the team at the Texas Childrens Hospital Center for Vaccine Development at Baylor College of Medicine, led by Drs. Maria Elena Bottazzi and Peter Hotez, worked on their patent-free vaccine with donated money in relative obscurity, failing to garner much outside interest.

Then one thing finally broke through and spoke to the people who had been overlooking their open-science approach to the vaccine known by its first producer as Corbevax. It came without strings or a secret formula, making it a true humanitarian pursuit that could finally reach the unvaccinated corners of the developing world.

Corbevax to beat inequity? read a CNN News ticker beside a televised interview with the scientists last month.

Now, just weeks after their vaccine won emergency use authorization in India, international news agencies are lining up for interviews. Curious investors are reaching out to the scientists on social media from around the world. U.S. lawmakers from both sides of the aisle are pressuring President Joe Biden to step in and support the vaccines distribution abroad.

The vaccine is being praised by scientists, members of the public and the media as the worlds COVID vaccine, the vaccine game changer and the way out of this global pandemic.

Theres even talk of a Nobel Peace Prize.

You are providing sorely needed ethical & scientific leadership. Texas should be proud! Ambassador Martin Kimani, Kenyas permanent representative to the United Nations, wrote on Twitter in early January.

And all of this buzz before a single shot of Corbevax has gone into an arm outside of clinical trials.

I think one of the reasons its been a bit viral is the fact that everybodys been talking about equity, equity, equity and nobody does much of anything, Bottazzi told The Texas Tribune. And then all of a sudden they learn that we have this vaccine that has been open science, with no proprietary technology. And theyre saying, Wait, where has this been?

The vaccine formula can be licensed by a vaccine producer in any low- or middle-income nation, which would then take ownership of it, produce it, name it and work with the government to get it to the people, Hotez said.

Corbevax, as it was dubbed by its Indian maker, was co-developed and manufactured by the biopharmaceutical company Biological E. Limited, headquartered in Hyderabad, India.

Doses are expected to be delivered to the Indian government starting next week for distribution to some half a billion people who are still unvaccinated in that country. Just over half the population of India is fully vaccinated, with another homegrown vaccine available there and a third recently authorized.

A halal version of the vaccine, for use in Islamic countries because it doesnt contain animal-based ingredients, is in clinical trials in Indonesia.

The protein-based COVID-19 vaccine technology is also licensed to vaccine producers in Bangladesh, South Africa and Botswana, with potential deals also in the works for Taiwan and Vietnam.

Those five countries alone are home to a billion people who are not fully vaccinated.

Hopefully, it will be game-changing for many countries, Bottazzi said.

Bottazzi and Hotez, both pioneers in the field of immunology, run Baylors National School of Tropical Medicine and have been developing coronavirus vaccines for more than a decade, including formulas for the SARS and MERS viruses.

Their vaccine uses the same recombinant protein technology already used for decades in the hepatitis B vaccine, a common childhood shot.

The vaccine technology has no intellectual property rights attached to it. That means the building blocks of the vaccine can be had for the price of a phone call. Once produced, the vaccine can be sold to governments for far less than any other vaccine currently on the market.

Our intent was to make it available to millions of people in the world who would otherwise not have access to COVID vaccines, said Hotez, dean of Baylor College of Medicines National School of Tropical Medicine.

The Indian government has secured a deal with Biological E to buy at least 300 million doses for less than $2 per dose. After that, Bio E has said it can make more than 1 million doses per month.

By comparison, the U.S. government is paying Pfizer about $20 per dose. Much of that is the cost of the intellectual property covered by the patent.

The idea of open science, open access and open source medicine and technology, like the patent pledge by Tesla in 2014, is not new, but its gaining traction for its focus on equal access over profit. Its critics argue that it can dampen competition and innovation.

There have been attempts to exempt COVID-19 vaccines from intellectual property rights and patents to increase global access, amid debate over whether that would result in more equitable distribution.

But much of the praise for Corbevax and its Texas inventors seems to be their willingness and that of Bio E and the investors to forgo a large profit in favor of the more altruistic goal of better access and distribution of the vaccine.

Last week, Bottazzi and Hotez were nominated for the Nobel Peace Prize for practicing what Hotez calls Texas vaccine diplomacy, by creating a path for the entire world to be inoculated.

Dr. Hotez and Dr. Bottazzis effort to develop the Corbevax vaccine is truly one of international cooperation and partnership to bring health, security, and peace around the world by creating a COVID-19 vaccine and making it available and accessible to all, wrote U.S. Rep. Lizzie Fletcher, D-Houston, in her official nomination. It is a contribution that is of the greatest benefit to humankind.

Whether their new fame translates into dollars for continuing their work on advancing the coronavirus vaccine program remains to be seen, Bottazzi said.

She hopes that once the vaccine's safety data is published for peer review and the vaccine starts going into arms, more support will follow.

They have some powerful voices showing up for them now, too. U.S. Rep. Michael McCaul, R-Austin, called on Biden last week to help with its distribution to American allies overseas who are struggling with what he called ineffective and substandard vaccines from China and Russia.

While we recognize existing administration efforts to supply COVID-19 vaccines around the world, the global supply is woefully insufficient to meet urgent and pressing demands, McCaul wrote in a letter signed by a bipartisan group of more than a dozen members of the Texas congressional delegation.

All the Corbevax praise is coming in before the scientific trial data has been published in a peer-reviewed scientific journal, seen by experts as an important public vetting process for a new vaccine or medication.

Im excited about it. I see a huge potential. I cant wait for something like this to come to fruition, said Dr. Jason Morrow, a physician and medical ethicist at the University of Texas Health Science Center at San Antonio. And I also have to be measured and patient and wait for the data.

Data from company-run clinical trials in India proving that Corbevax is safe and effective was submitted to the Indian government regulators to review before they authorized it on Dec. 28 for emergency use.

Long before that, in the U.S., the Texas Childrens team published all of its information about the production processes for the vaccine technology in publicly available scientific journals.

The clinical trial results are not on the Indian regulators website yet, although early results have been released by the company and the team in public statements.

Biological E Limited reported during the approval process in India that in the companys clinical trials, Corbevax showed up to a 90% efficacy rate based onimmune-bridging studies, and none of the 3,000 people who participated in the final stage ofclinical trials had any serious adverse reactions. It also showed only a minimal drop in protection after six months.

When the companys testing methods and research are published in a scientific journal, that will give the public a look into how the researchers came to their conclusions about Corbevaxs effectiveness. Meanwhile, its creating some tension with those who want to support it but dont have all the facts yet.

The fact that its [Corbevax] open source, and its intended to be easy and cheap to make and to do so at a large scale is really exciting, and its exactly what we need to try to get the pandemic under control, Morrow said. But we need to see the data.

The data for all the clinical trials, which began over a year ago, is expected to be published within weeks or even days, Bottazzi said.

In 2020, the Houston teams work was passed over for funding by Operation Warp Speed, the public-private partnership created by the federal government to accelerate treatments and vaccines for COVID-19. Developing the COVID-19 vaccine technology and the co-development efforts of Corbevax from the lab to authorization cost the laboratories between $5 million and $7 million, Bottazzi said.

Thats when philanthropy stepped in, specifically the Robert J. Kleberg, Jr. and Helen C. Kleberg Foundation, the M.D. Anderson Foundation and the JPB Foundation in New York, along with several other anonymous individual donors.

Even Love, Titos, the philanthropic arm of Austin-based Titos Handmade Vodka, put in $1 million.

By comparison, Operation Warp Speed spent more than $12 billion in federal tax dollars to develop and distribute the vaccines launched by Pfizer, Moderna and Johnson & Johnson. The three vaccines have been used to fully vaccinate nearly two-thirds of the U.S. population.

Those companies vaccines use messenger RNA, a molecule the virus needs to produce a spike protein and bind to human cells, to prompt the immune system to produce antibodies against that protein.

Its a method thats been in development since the 1970s and in clinical trials since 2008. Whats new about the mRNA vaccines are the systems for producing and delivering them in mass quantities. Thats the part that was patented by the mRNA vaccines creators in exchange for the pharmaceutical companies Pfizer and Moderna investing in the science behind it and funding the research. The cost of that investment gets passed on to the buyers, which include governments.

And the richer the government, the more vaccines it can buy. Some poor governments cant afford any at all, and they rely on donations from other countries, like the U.S., for what little vaccine they can get.

The Corbevax formula is also not new but unlike the mRNA shots, its recombinant protein technology has been in widespread use globally for decades. In some ways, that familiarity and older technology is what put Corbevax behind the newer, more modern mRNA vaccines in the race for funding two years ago.

Now the lack of a patent and the fact that the formula that can be replicated almost anywhere is flipping the script, making Corbevax the new and buzz-worthy vaccine while others can get bogged down in vaccine hesitancy, cost, production limitations and politics.

They [Hotez and Bottazzi] have found a way to get enough money to develop it without the people who are providing the money demanding intellectual property protection, said Dr. Benjamin Neuman, a Texas A&M University virologist who has been doing coronavirus research since 1996. Thats the trick. Finding a funder that is willing to say, Heres the money, lets do this for people everywhere, you know?

Every week, Bottazzi and Hotez field calls from more nations that are interested in the vaccine, that want to know how to obtain it and how to make it.

The World Health Organization is expected to issue an emergency use listing in the coming months for Corbevax, which could help fast-track it in other countries that need it.

For answers as to why vaccine equity in low- and middle-income countries matters, doctors say to look at the ravages of the omicron wave, which is just starting to subside nationwide and in Texas.

More than 64% of the worlds population has gotten at least one dose of a COVID-19 vaccine, but the vast majority of those people are concentrated in wealthier, more developed countries, nations that are predominantly white. Only 10% of the people in poorer countries have received at least one shot.

An article published in the medical journal The Lancet last month, authored by a handful of scientists including Hotez, warned of the alarming inequities in access to testing, treatment and vaccines by poorer countries that have set the tone of this pandemic.

By September 2021, they wrote, 5.82 billion vaccine doses had been administered worldwide. Less than 2% of the people in less wealthy countries had received at least one dose.

Nations like Kenya, Uganda and South Africa, where the omicron variant was first publicly reported last Thanksgiving, are still dealing with vaccination rates ranging from 4% to under a third of the population.

Scientists have never confirmed a country of origin for omicron, and it was documented in white, wealthy, western European areas around the same time it was being reported by South Africa, but with no apparent geographical connection.

But the high numbers of unvaccinated people found in poorer countries make them particularly vulnerable to the ravages of new variants, experts say.

The World Health Organization estimates that for the pandemic to wane globally, vaccines should reach 70% of the world by mid-2022. Currently, about 3 billion people are still unvaccinated, and up to 9 billion doses are needed to get them all fully vaccinated and boosted.

Reducing virus spread abroad means fewer infections in the United States and Texas. It took less than a month between the time the omicron variant was first reported in South Africa and Europe and the time it was breaking records in some major Texas hospitals.

We all have an interest in everybody getting the vaccine, and that means we really need to build systems that can ensure equity, said Dr. Rachel Pearson, a hospital pediatrician at the Center for Medical Humanities and Ethics at UT Health San Antonio. We really need to have a more integrated global system with a focus on access in the developing world, because vaccine inequity has been a major source of unnecessary death and suffering.

Disclosure: Texas Childrens Hospital, the University of Texas Health Science Center at San Antonio, Titos Handmade Vodka and Texas A&M University have been financial supporters of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribunes journalism. Find a complete list of them here.


More here:
From obscurity to a Nobel Prize nomination: Houston scientists acclaimed for their patent-free COVID-19 vaccine - The Texas Tribune
Michigan COVID: Heres what to know Feb. 11, 2022 – WDIV ClickOnDetroit

Michigan COVID: Heres what to know Feb. 11, 2022 – WDIV ClickOnDetroit

February 11, 2022

DETROIT Michigan reported 7,527 new cases of COVID-19 and 330 virus-related deaths Wednesday -- an average of 3,763.5 cases over a two-day period.

The deaths announced Wednesday include 239 identified during a Vital Records review.

Wednesdays update brings the total number of confirmed COVID cases in Michigan to 2,026,646, including 30,747 deaths. These numbers are up from 2,019,119 cases and 30,417 deaths, as of Monday.

Testing has increased to around 50,000 to 60,000 diagnostic tests reported per day on average, with the 7-day positive rate at 17.66% as of Feb. 9 -- the lowest it has been since mid-December. Hospitalizations have decreased over the last three weeks.

Ad

The states 7-day moving average for daily cases was 3,890 on Wednesday, Feb. 9, lower than the previous week. The 7-day death average was 93 on Feb. 9. The states fatality rate is 1.5%.

Michigan has reported more than 11.2 million doses of the COVID-19 vaccine administered as of Feb. 1, with 69.8% of 16+ residents having received at least one dose, while 63.9% of 16+ residents are considered fully vaccinated.

Across Michigans entire population, 65.5% have received at least one COVID vaccine dose.

According to Johns Hopkins University, more than 76 million cases have been reported in the U.S., with more than 902,200 deaths reported from the virus. Globally, more than 10 billion vaccine doses have been administered, including more than 539 million doses in the U.S. alone.

Ad

Worldwide, more than 393 million people have been confirmed infected and more than 5.7 million have died, according to Johns Hopkins University. The true numbers are certainly much higher, because of limited testing, different ways nations count the dead and deliberate under-reporting by some governments.

VIEW: Tracking coronavirus cases, outbreaks in Michigan schools

Jan. 19, 2022: For the first time since the start of the COVID omicron surge in Michigan, hospital officials with the Henry Ford Health System said theyre starting to see some signs of early progress.

Ad

These trends are aligning and pointing in the right direction, said Bob Riney, president of health care operations and COO at Henry Ford Health.

Read here.

Michigan COVID-19 daily reported cases since Jan. 1:

Jan. 1 -- 12,247 new cases

Jan. 2 -- 12,247 new cases

Jan. 3 -- 12,247 new cases

Jan. 4 -- 13,673 new cases

Jan. 5 -- 13,673 new cases

Jan. 6 -- 20,346 new cases

Jan. 7 -- 20,346 new cases

Jan. 8 -- 14,841 new cases

Jan. 9 -- 14,841 new cases

Jan. 10 -- 14,842 new cases

Jan. 11 -- 14,229 new cases

Jan. 12 -- 14,229 new cases

Jan. 13 -- 18,557 new cases

Jan. 14 -- 18,557 new cases

Jan. 15 -- 17,201 new cases

Jan. 16 -- 17,202 new cases

Jan. 17 -- 17,202 new cases

Jan. 18 -- 17,202 new cases

Jan. 19 -- 17,202 new cases

Jan. 20 -- 16,775 new cases

Jan. 21 -- 16,776 new cases

Jan. 22 -- 13,124 new cases

Jan. 23 -- 13,124 new cases

Jan. 24 -- 13,124 new cases

Jan. 25 -- 13,711 new cases

Jan. 26 -- 13,712 new cases

Jan. 27 -- 13,155 new cases

Jan. 28 -- 13,154 new cases

Jan. 29 -- 7,080 new cases

Jan. 30 -- 7,081 new cases

Jan. 31 -- 7,081 new cases

Feb. 1 -- 9,401 new cases

Feb. 2 -- 9,402 new cases

Feb. 3 -- 4,902 new cases

Feb. 4 -- 4,903 new cases

Feb. 5 -- 3,299 new cases

Feb. 6 -- 3,299 new cases

Feb. 7 -- 3,300 new cases

Feb. 8 -- 3,764 new cases

Feb. 9 -- 3,763 new cases

Michigan COVID-19 daily reported deaths since Jan. 1:

Jan. 1 -- 60 new deaths

Jan. 2 -- 60 new deaths

Jan. 3 -- 60 new deaths (172 from past five days from vital records)

Jan. 4 -- 138 new deaths

Jan. 5 -- 139 new deaths (165 from past two days from vital records)

Jan. 6 -- 129 new deaths

Jan. 7 -- 130 new deaths (136 from past two days from vital records)

Jan. 8 -- 18 new deaths

Jan. 9 -- 19 new deaths

Jan. 10 -- 19 new deaths

Jan. 11 -- 175 new deaths

Jan. 12 -- 175 new deaths (282 from past two days from vital records)

Jan. 13 -- 125 new deaths

Jan. 14 -- 126 new deaths (140 from past two days from vital records)

Jan. 15 -- 100 new deaths

Jan. 16 -- 100 new deaths

Jan. 17 -- 100 new deaths

Jan. 18 -- 100 new deaths

Jan. 19 -- 101 new deaths (346 from past two days from vital records)

Jan. 20 -- 105 new deaths

Jan. 21 -- 105 new deaths (79 from past two days from vital records)

Jan. 22 -- 12 new deaths

Jan. 23 -- 12 new deaths

Jan. 24 -- 12 new deaths

Jan. 25 -- 190 new deaths

Jan. 26 -- 189 new deaths (268 from past two days from vital records)

Jan. 27 -- 86 new deaths

Jan. 28 -- 87 new deaths (121 from past two days from vital records)

Jan. 29 -- 21 new deaths

Jan. 30 -- 22 new deaths

Jan. 31 -- 22 new deaths

Feb. 1 -- 163 new deaths

Feb. 2 -- 164 new deaths (239 from past two days from vital records)

Feb. 3 -- 104 new deaths

Feb. 4 -- 105 new deaths (155 from past two days from vital records)

Feb. 5 -- 12 new deaths

Feb. 6 -- 13 new deaths

Feb. 7 -- 13 new deaths

Feb. 8 -- 165 new deaths

Feb. 9 -- 165 new deaths (239 from past two days from vital records)

Coronavirus resources:

Join our dedicated space to discuss the pandemic. Youre invited to share questions, experiences, insights and opinions.


Read this article:
Michigan COVID: Heres what to know Feb. 11, 2022 - WDIV ClickOnDetroit
Covid-19 update: Daily Covid infections near quarter million in Germany – Pharmaceutical Technology

Covid-19 update: Daily Covid infections near quarter million in Germany – Pharmaceutical Technology

February 11, 2022

Global: The global Covid death toll has passed 5.7 million, with a figure of 5,789,807 according to researchers at Johns Hopkins University. Meanwhile, infections have raced past 400 million to a world wide figure of 405,994,662.

Daily infections are nearing the quarter million mark in Germany, as the country reported 247,862 new Covid-19 cases, compared with 234,250 the day before, according to the countrys public health authority RKI.

Novavax says its Covid vaccine has proved safe and effective in a study of 12- to 17-year-olds. Armed with the new data, Novavax plans to soon seek expanded use of its shots down to age 12. Later this year, it plans to begin testing in younger children.

US: Covid -19 infections have now passed 77.4 million. Meanwhile, the US coronavirus death toll has increased to more than 915,000 according to Johns Hopkins University data.

Nevada will no longer require masks in public, Governor Steve Sisolak announced Thursday in a press briefing. Earlier this week, other states with Democratic governors, including New York, New Jersey and Illinois, announced an easing of masking rules as the surge of infections caused by the Omicron variant subsides.

Federal, state and local law-enforcement agencies across the US are bracing for the possibility of a protest by truckers that could begin this weekend and carry into March, potentially including a cross-country caravan and disruptions to cities and major transportation routes. While its still not clear how serious the threat is, the US Department of Homeland Security warned law-enforcement agencies that protests could begin 13 February when the Super Bowl is played in Los Angeles and arrive in the nations capital in early March. Truckers could time their protests to coincide with President Joe Bidens State of the Union Speech on 1 March, according to a DHS alert.

Canada: The city of Windsor, Ontario, is seeking a court injunction to end the protest that has blocked freight traffic on the Ambassador Bridge for nearly 72 hours, setting the stage for a potential confrontation with demonstrators. A provincial court will hear the application at 12 p.m. New York time Friday, a city spokesperson said. A court order would clear the path for police to make arrests or tow vehicles to clear the streets, if necessary, Windsor Mayor Drew Dilkens said. The legal move comes as protesters are digging in at the base of the bridge that connects Windsor with Detroit. Police have tried to persuade them to move to an area that doesnt block traffic, to no avail, Dilkens said in an interview.

EU: Brussels authorities have banned a pan-European freedom convoy of motorists protesting Covid restrictions from entering the Belgian capital, the regional government said in a statement. Reuters reports the convoy was expected to arrive at the home of European Union institutions and NATO on Monday. Authorities in Paris had earlier banned the convoy.

Spain: Spain dropped the mandatory use of face masks outdoors. Although they will remain compulsory at large open-air gatherings where social distancing is not possible, they will no longer be required in school playgrounds.

Netherlands: The Dutch government has said it aims to drop most of its coronavirus restrictions by the end of the month, as record levels of infections in recent weeks have only had a limited effect on hospital numbers.

UK: The UK recorded another 66,638 Covid infections and a further 206 deaths within 28 days of a positive test, according to the latest data on the governments coronavirus dashboard.

Meanwhile, Covid passes are to be scrapped and the need to wear face coverings in certain venues removed later this month as coronavirus cases continue to fall, the Welsh government has announced. The changes will be confirmed on Friday during the first three-week review of Waless alert level zero measures.

Finland: Finland will end testing and contact tracing for the majority of the population, leaving it up to people to test at home and isolate on their own when they have contracted the virus. Testing and contact tracing will focus more on high-risk groups, pregnant women, health-care and social workers, according to a statement on Thursday.

Italy: Italian outdoor and indoor nightclubs will reopen Friday. Access will be allowed only to those showing a reinforced green pass, which can only be obtained with the vaccine or after recovering from Covid. Mandatory use of masks open-air in will end all over the country.

New Zealand: New Zealand has hit a new record daily of community Covid cases, with 446 announced on Friday. That is an increase of 140 cases from the previous record, which was set the previous day. Cases are expected to climb steadily now that Omicron is spreading within New Zealand.

More people have arrived outside New Zealands parliament, as protesters calling for an end to a vaccine mandate and Covid-19 restrictions refused to end their demonstrations despite arrests by the police. Its been four days since protesters, inspired by truckers demonstrations in Canada, occupied the parliament lawns in the capital Wellington.

Australia: Australias immunization advisory body has recommended three doses of vaccine be required for people aged 16 and over to be considered fully vaccinated. People should not be considered up-to-date with their vaccinations if they have not received a booster within six months of their second dose of vaccine, the Australian Technical Advisory Group on Immunisation said in its clinical advice, updated on Thursday. The application of the advice was up to governments and private entities, it said. People who have had Covid-19 can defer their next dose for as long as four months after infection, down from ATAGIs previous recommendation of six months. Boosters are not recommended for people aged 5 to 15, it said.

China: China will fully support Hong Kong with its dynamic zero coronavirus strategy, its office overseeing matters in the city said, as the territory is expected to hit a new record for daily infections on Friday. The global financial hub will report at least 1,325 new coronavirus cases on Friday, broadcaster TVB reported, a new record.

Hong Kong: Hong Kongs current social distancing rules wont stop deaths, and nearly 1,000 residents may die by mid-June if there arent changes, according to researchers from the University of Hong Kong. Mitigation measures are needed to cut transmissions by 85% to get through the outbreak while minimizing fatalities, researchers said. The ultimate number of deaths depends on how long the city sustains the curbs now in place and any changes to them.

Africa: Africa is transitioning out of the pandemic phase of its Covid outbreak and moving towards a situation where it will be managing the virus long term, the World Health Organizations regional head for Africa said. Dr Matshidiso Moeti also said the number of Covid infections in Africa could be seven times higher than official data suggested, and deaths from the virus two to three times higher.

South Africa: The Omicron BA.2 subvariant makes up almost 100% of new coronavirus infections in South Africa, Tulio de Oliveira, a bio-informatics professor who runs gene-sequencing institutions and advises the countrys government on the pandemic, said on Twitter. BA.2 appears to be more transmissible than the original Omicron variant. There is no indication that it causes more severe disease. However, while South Africa was the first country to experience a major Omicron wave, the number of infections has tapered off. On Wednesday the country reported 3,628 new cases, down from a record of almost 27,000 on 15 December.

Americas: At least six auto plants around the US-Canada border have temporarily halted work as the impact from a protest blocking truck traffic into Detroit begins rippling through both nations economies. Toyota Motor Corp. said it will idle three plants in Ontario due to parts shortages caused by the bridge blockade. General Motors Co. canceled the evening shift Wednesday and Thursdays day shift at an SUV factory in Lansing, Michigan. Ford Motor Co. shut down an engine plant and cut the schedule at an assembly plant, both in Ontario, while Stellantis NV canceled shifts Wednesday night at multiple facilities in the US and Canada.

UK: AstraZeneca Plc plans to expand a new unit focused on vaccines and immune therapies rather than sell it or spin it off, Chief Executive Officer Pascal Soriot said in an interview. The business has been in the spotlight since the UK drugmaker in November announced its creation to focus on its Covid-19 shot, antibody combination and products targeting respiratory infections.

GlobalData exists to help businesses decode the future to profit from faster, more informed decisions.

Software Solutions for Tracking and Monitoring Pharma Cargo

Dry Power and Liquid-Based Material Handling Systems for Pharmaceuticals


Read more:
Covid-19 update: Daily Covid infections near quarter million in Germany - Pharmaceutical Technology
Massachusetts administered 80,600 doses of COVID-19 vaccines within 7 days – WWLP.com

Massachusetts administered 80,600 doses of COVID-19 vaccines within 7 days – WWLP.com

February 11, 2022

CHICOPEE, Mass. (WWLP) The State Department of Public Health also released its weekly report on vaccination progress in Massachusetts.

For the week of February 10, the state administered 80,626 doses of COVID-19 vaccines. There are 5.2 million people are now fully vaccinated here in Massachusetts. The state considers people with two doses of either Pfizer or Moderna or one dose of Johnson and Johnson to be fully vaccinated.

School vacation week is right around the corner, but with COVID-19 still spreading, some parents may be concerned about the vaccination rate for their vacation destination. According to data from the Mayo Clinic, the highest vaccination rates in the U.S. are along the east coast.

Vermont leads the way with a nearly 80 percent vaccination rate. Followed by Rhode Island, Maine and Connecticut. The South is seeing the lowest vaccination rates. Louisiana, Arkansas, Mississippi, Alabama, Tennessee, and Georgia have the lowest.

The Mayo Clinic reports that Alabama and Wyoming are the only states to have vaccination rates under 50 percent.


Original post:
Massachusetts administered 80,600 doses of COVID-19 vaccines within 7 days - WWLP.com
Increasing Public Criticism, Confusion Over COVID-19 Response in U.S. – Pew Research Center

Increasing Public Criticism, Confusion Over COVID-19 Response in U.S. – Pew Research Center

February 11, 2022

CDC Director Rochelle Walensky and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the president, testify before a Senate committee hearing on the federal response to COVID-19 on Jan. 11 on Capitol Hill in Washington. (Greg Nash/Pool via AP)

Pew Research Center conducted this study to understand how Americans are continuing to respond to the coronavirus outbreak. For this analysis, we surveyed 10,237 U.S. adults from Jan. 24 to 30, 2022.

Everyone who took part in the survey is a member of the Centers American Trends Panel (ATP), an online survey panel that is recruited through national, random sampling of residential addresses. This way, nearly all U.S. adults have a chance of selection. The survey is weighted to be representative of the U.S. adult population by gender, race, ethnicity, partisan affiliation, education and other categories. Read more about the ATPs methodology.

Here are the questions used for this report, along with responses, and its methodology.

Nearly two years after the coronavirus outbreak took hold in the United States, Americans are increasingly critical of the response to COVID-19 from elected officeholders and public health officials.

Amid debates over how to address the surge in cases driven by the omicron variant, confusion is now the most common reaction to shifts in public health guidance: 60% of U.S. adults say theyve felt confused as a result of changes to public health officials recommendations on how to slow the spread of the coronavirus, up 7 percentage points since last summer.

Americans are now almost evenly divided over how well public health officials, such as those at the Centers for Disease Control and Prevention, are responding to the outbreak, with about half (49%) saying they are doing an only fair or poor job and half (50%) saying they are doing an excellent or good job. Positive ratings of public health officials have fallen 10 points since August and are well below ratings for their initial response to the outbreak in early 2020.

Evaluations of elected leaders at all levels of government have also moved lower. A majority (60%) now describes the job Joe Biden is doing responding to the coronavirus as only fair or poor. The share of Americans who say Biden is doing an excellent or good job (40%) is down 7 points since August and is now only slightly higher than the share who said Donald Trump did an excellent or good job responding to the coronavirus outbreak over the course of his presidency (36%).

The new Pew Research Center survey finds that 78% of U.S. adults say they have received at least one dose of a COVID-19 vaccine, including 73% who say they are fully vaccinated having received either two Pfizer or Moderna vaccines or one Johnson & Johnson. Among fully vaccinated adults, 66% say theyve received an additional COVID-19 booster shot within the past six months (this group makes up 48% of all U.S. adults). When it comes to the decision to get a vaccine:

Among Republicans, the decision to get a vaccine, as well as broader views on the outbreak, differ across key demographics and characteristics. For instance, age and education strongly shape the vaccine decision among Republicans:

With vaccines widely available, businesses and institutions are grappling with whether to require proof of COVID-19 vaccination to participate in a range of activities. The survey finds:

Partisan gaps on vaccine requirements are among the largest of any seen in the survey. Majorities of Republicans oppose vaccine requirements for all five activities listed in the survey, while majorities of Democrats favor them. For instance, 76% of Democrats favor requiring proof of COVID-19 vaccination to attend a sporting event or concert, compared with just 26% of Republicans.

Not surprisingly, unvaccinated adults broadly oppose all vaccine requirements, while those who have received a vaccine support most of these measures.

Views on vaccine requirements highlight how partisanship and vaccine status are intertwined, yet both factors play a role shaping views. Among Republicans, those who have received a vaccine are more open to vaccination requirements than those who have not received a vaccine. On air travel, for example, 43% of Republicans who have received a vaccine say they would favor requiring proof of vaccination to travel by plane. Just 9% of Republicans who have not received a vaccine favor this.

One big change seen in the new survey is the increased comfort Americans express around everyday activities. Large shares now say they are comfortable visiting with close family and friends in their home (85%) and going to the grocery store (84%). Majorities also say they feel comfortable visiting a hair salon or barbershop (73%) or eating out in a restaurant (70%). Comfort levels with most activities in the survey are roughly 20 percentage points higher than in November of 2020, before the availability of COVID-19 vaccines in the U.S.

In part, these gaps in comfort tie to the finding that adults who have not received a vaccine are less concerned than vaccinated adults about getting a serious case of the coronavirus themselves. This has been the case throughout the outbreak. Levels of personal concern about the disease have been one of the core factors tied to the decision of whether or not to get vaccinated since vaccines became widely available.

These are among the principal findings from Pew Research Centers survey of 10,237 U.S. adults conducted from Jan. 24 to 30, 2022, on the coronavirus outbreak and Americans views of a COVID-19 vaccine.

The rise in cases spurred by the omicron variant put renewed focus on vaccination rates in the U.S. as well as the role booster shots play in limiting the impacts from the coronavirus.

Overall, 78% of U.S. adults say they have received at least one dose of a COVID-19 vaccine, including 73% who say they are fully vaccinated (5% say theyve received one shot, but need one more). According to the Centers for Disease Control and Prevention (CDC), fully vaccinated means having received two doses of Pfizer or Moderna vaccines or one dose of the Johnson & Johnson.

Two-in-ten U.S. adults say they have not received a vaccine for COVID-19. These estimates generally align with other national public opinion surveys, including those conducted by the Kaiser Family Foundation.

When it comes to booster shots, the current survey finds that 66% of adults who are fully vaccinated against COVID-19 say they have also received a booster shot within the last six months. This group makes up 48% of all U.S. adults.

There continue to be sizable differences across groups in the shares who say have received at least one dose of a COVID-19 vaccine (78% of all U.S. adults).

Among the largest differences is partisan affiliation: Democrats and those who lean to the Democratic Party are 26 percentage points more likely than Republicans and Republican leaners to say theyve received a COVID-19 vaccine (90% vs. 64%).

White evangelical Protestants continue to be less likely than other major religious groups to say they have gotten vaccinated for COVID-19. About six-in-ten White evangelical Protestants (62%) have received at least one dose of a COVID-19 vaccine, compared with 77% of White non-evangelical Protestants, 80% of religiously unaffiliated adults and 85% of Catholics.

Those with higher levels of education and income are more likely than those with lower levels to say they have received a vaccine for COVID-19. And those with health insurance are 16 points more likely than those without to have gotten a vaccine.

Some demographic differences in vaccination status are more pronounced within one partisan group than another. For instance, 80% of Republicans ages 65 and older say they have received a COVID-19 vaccine, compared with far fewer Republicans 18 to 29 (52%). There is a much more modest gap between the shares of Democrats 65 and older and those 18 to 29 who say theyve received a vaccine (94% vs. 88%). See the Appendix for more details on vaccination status within partisan groups.

Among those who are fully vaccinated against COVID-19, Democrats and Democratic leaners are more likely to say theyve received a booster shot within that last six months than Republicans and GOP leaners.

About three-quarters of fully vaccinated Democrats (73%) say they have received a COVID-19 booster shot within the last six months. This group makes up 62% of all Democrats.

Among fully vaccinated Republicans, 55% say they have received a COVID-19 booster shot within the last six months (33% of all Republicans).

Public health experts are continuing to evaluate whether to recommend regular COVID-19 booster shots.

The survey finds that 64% of adults who have received a COVID-19 vaccine say they would probably be willing to get a vaccine booster about every six months, if public health officials recommended it; 35% of vaccinated adults say they probably would not be willing to get a booster shot every six months or so.

Among adults who have received a COVID-19 vaccine, Democrats and Democratic-leaning independents are far more likely than Republicans and Republican leaners to say theyd be willing to get a booster shot regularly (77% vs. 42%).

A large majority of Americans (81%) continue to say hospitals and medical centers in their area are doing an excellent or good job responding to the coronavirus.

Ratings are far less positive for the performance of public health officials and elected officeholders at the state, local and federal level.

Half of Americans now say public health officials, such as those at the CDC, are doing an excellent or good job responding to the outbreak, down from a high of 79% early in the outbreak and from 60% last August.

The same share (50%) say their local elected officials are doing an excellent or good job responding to the coronavirus outbreak, and 46% say this about their state elected officials. Ratings for both groups are down since August and are much lower than they were at earlier stages of the outbreak.

Four-in-ten say Joe Biden is doing an excellent or good job dealing with the coronavirus, compared with 60% who say he is doing an only fair or poor job. Positive ratings for Bidens performance dealing with the coronavirus have continued to decrease, down 7 percentage points since August and 14 points since February 2021, shortly after his inauguration as president. The share of Americans with a positive view of Bidens handling of the coronavirus outbreak is now nearing that for Trump after he left office (36%).

Republicans are especially critical of the response to the coronavirus outbreak by public health officials. Just 26% of Republicans and Republican leaners say public health officials, such as those at the CDC, are doing an excellent or good job; a majority (73%) say they are doing an only fair or poor job. By contrast, 69% of Democrats and Democratic leaners rate the job health officials are doing as excellent or good.

This contrasts with views of public health officials measured in the early stages of the coronavirus outbreak. For instance, in May of 2020, during Trumps administration, 68% of Republicans and 75% of Democrats said public health officials were doing an excellent or good job responding to the outbreak.

Partisans continue to offer starkly different ratings of Bidens response to the coronavirus outbreak: 64% of Democrats now say he is doing an excellent or good job, while 89% of Republicans say instead that he is doing an only fair or poor job.

Partisan gaps are more modest in ratings of state and local elected officials, and majorities of both Republicans (76%) and Democrats (86%) say hospitals and medical centers in their area are doing an excellent or good job responding to the coronavirus outbreak.

Americans have encountered a number of changes to public health guidelines about how to slow the spread of the coronavirus in the U.S. over the past two years.

When asked how theyve felt about these changes, confusion is the top reaction Americans express: 60% say they have felt confused by changes in recommendations on how to slow the spread of the coronavirus, up 7 percentage points from the share who said this in August 2021.

Nearly as many (57%) say changes in health officials recommendations on how to slow the spread made them wonder if public health officials were holding back important information. And 56% say it made them feel less confident in the recommendations. The share saying theyve felt less confident in public health officials recommendations is up 5 points since August.

Changing health guidance has also prompted some positive reactions from the public: 56% say theyve felt that these changes made sense because scientific knowledge is always being updated. Still, the share who say theyve felt this way is down 5 points since last summer. Fewer Americans (43%) say changes to health officials recommendations on how to slow the spread of the coronavirus made them feel reassured that officials were staying on top of new information, down 8 points since August.

Vaccinated adults express much more positive reactions to changing public health guidance on how best to slow the spread of the coronavirus than adults who have not received a vaccine. Partisan affiliation also strongly shapes views, with Democrats taking a more positive view of changes in recommendations than Republicans.

Two-thirds (66%) of adults who have received a COVID-19 vaccine say changes in recommendations have made sense because scientific knowledge is always being updated; just 26% of adults who have not received a vaccine express this view.

Negative reactions register more widely with adults who have not received a vaccine than those who have. Still, 50% of vaccinated adults say changes in guidance on how to slow the spread of the coronavirus have made them less confident in health officials recommendations, and 58% say theyve made them feel confused.

Democrats and Democratic leaners are 38 points more likely than Republicans and Republican leaners to say changes in officials coronavirus recommendations have made sense because scientific knowledge is always being updated (74% vs. 36%). About three-quarters of Republicans say changes in guidance have made them wonder if public health officials were holding back important information and made them less confident in health officials recommendations (about four-in-ten Democrats express each of these reactions).

The partisan gap is more modest when it comes to confusion: 69% of Republicans and 53% of Democrats say theyve felt confused due to changes in public health officials coronavirus recommendations.

Americans are now much more comfortable with a range of daily activities than they were in November 2020, before the availability of COVID-19 vaccines in the U.S.

Most Americans (85%) now say they feel comfortable visiting with a close friend or family member inside their home, up 20 percentage points from the share who said this in November 2020. About as many (84%) say they feel comfortable going to the grocery store.

Majorities also say they are now comfortable going to a hair salon or barbershop (73%) or eating out in a restaurant (70%). In late 2020, far smaller shares of Americans felt comfortable doing these activities (53% and 44%, respectively).

Still, fewer than half say they feel comfortable attending an indoor sporting event or concert (43%) or a crowded party (34%), though these percentages have risen substantially since November 2020.

The 20% of U.S. adults who have not received a vaccine are less likely than vaccinated adults to see the coronavirus outbreak as a major threat to their own personal health. Consistent with lower levels of concern, unvaccinated adults tend to express more comfort with public activities than those who have received a COVID-19 vaccine.

For example, about six-in-ten (62%) of those who are not vaccinated say they feel comfortable attending an indoor sporting event or concert, compared with 37% of vaccinated adults. Unvaccinated adults are 29 points more likely than vaccinated adults to say theyre comfortable attending a crowded party and somewhat more likely to say theyre comfortable eating in a restaurant and going to a hair salon or barbershop.

Large shares of both vaccinated and unvaccinated adults now say theyre comfortable visiting with a close friend or family member inside their home and going to the grocery store.

Partisan affiliation also shapes views on this question, with Republicans and those who lean to the Republican Party more likely than Democrats and Democratic-leaning independents to say they feel comfortable engaging in a variety of activities.

A majority of Republicans (62%) say they are comfortable attending an indoor sporting event or concert, compared with about three-in-ten Democrats (27%). Theres a similar gap in comfort with attending a crowded party.

Large shares of both Republicans and Democrats say they are comfortable visiting with a close friend or family member inside their home or going to the grocery store, though the size of the majority is about 10 points higher among Republicans than Democrats in both cases.

A separate early-January survey found the share of U.S. adults who say they have worn a mask all or most of the time in stores and businesses over the last month increased from 53% in August of 2021 to 61% in January. Those who have received a COVID-19 vaccine (70%) continue to be far more likely than those who have not (32%) to say theyve been wearing a mask in public places regularly. See Appendix for more details.

A majority of U.S. adults (58%) favor requiring proof of COVID-19 vaccination before being allowed to travel by air.

Slightly more Americans favor (53%) than oppose (46%) a vaccine requirement to go to a sporting event or concert.

By 52% to 47%, more also favor than oppose requiring proof of COVID-19 vaccination for attending public colleges and universities in person. Support for this proposal is 5 percentage points lower than it was in August of 2021.

Americans lean against requiring proof of vaccination to eat inside of a restaurant (53% oppose, 46% favor), and 59% oppose requiring proof of vaccination to shop inside stores and businesses. Support for both of these proposals has also declined slightly since last summer.

Unsurprisingly, Americans who have not received a coronavirus vaccine are overwhelmingly against vaccine requirements, with around eight-in-ten or more opposing each of these measures.

There continue to be large partisan differences in how Americans view vaccination requirements. Majorities of Democrats favor requiring proof of vaccination status to do each of the five activities listed, while majorities of Republicans oppose requirements in each of these cases.

For example, eight-in-ten Democrats and independents who lean toward the Democratic Party favor requiring those traveling by airplane to show proof of vaccination, while only about three-in-ten (31%) Republicans and Republican leaners say they favor this.

Among Republicans, opposition to vaccine requirements is far more widespread among those who have not received a COVID-19 vaccine than among those who have. For instance, 43% of vaccinated Republicans favor requiring proof of COVID-19 vaccination for air travel, compared with just 9% of unvaccinated Republicans who say this. (Overall, 64% of Republicans and Republican leaners have received at least one dose of a COVID-19 vaccine; 33% have not.)


Excerpt from: Increasing Public Criticism, Confusion Over COVID-19 Response in U.S. - Pew Research Center
Opinion: Coronavirus and Regulating Access to High-Risk Pathogens – The Scientist

Opinion: Coronavirus and Regulating Access to High-Risk Pathogens – The Scientist

February 11, 2022

As the SARS-CoV-2 pandemic enters a third calendar year, the Department of Health and Human Services is poised to make key decisions about future access to the pathogen. This moment in history may prove to be an important inflection point in the regulation of emergent pandemic pathogens and is an occasion for careful reconsideration of the decision-making process. While regulation plays an important role in securing against accidental or intentional release of biological threats, missteps resulting in overregulation could stymie scientific progress, leading to deficiencies in public health preparedness and security infrastructure in the long term.

Todays list of the most dangerous biological agents, which is key to regulating their possession, use, and transfer, first took form in 1996 as a list of select infectious agents proposedby the Working Group on Civilian Biodefense. Throughout its history, the list has served as a mechanism for bolstering the biosecurity of the United States by preventing unauthorized access, theft, loss, or release of dangerous pathogens and toxins. This is orchestrated by the Federal Select Agents Program (FSAP), which rigorously reviews individual and laboratory requests to possess and work with restricted agents. In addition, the regulations guide regular inspections of laboratory facilities and protocols, review of import and transfer requests, and penalties in the case of failure to meet standards (see box below). Over time, the type and number of agents included have changed, and todays list contains 67 pathogens and toxins. The addition of a new agent is relatively unusual; however, it is reasonable to assume that additions of the future are likely to be emergent diseases with significant risks to global health security.

At first blush, SARS-CoV-2 may seem to fall squarely into this category. If added to the select agents list, it would be the first novel pandemic pathogen added since its close relative SARS-CoV-1 was included in 2012. But the decision isnt as simple as it may appear. Not every dangerous pathogen that emerges makes the listfor example, another deadly coronavirus, Middle Eastern Respiratory Syndrome-related coronavirus (MERS-CoV), was discovered in 2012 but has not been added. And pathogens including HIV and the bacterium causing tuberculosis, two diseases that represent a considerable proportion of the global infectious disease burden annually, have not made the cut, either.

Clearly, criteria beyond novelty, pandemic potential, and total fatalities factor into whether an agent is select. But these factors are not as clearly defined as one might think. Four general criteria were determined by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which considers the virulence or toxicity of an agent, its mode of transmission, and the availability of treatments. But from a critical analysis of agents on the list, its apparent that further, unwritten factors are routinely considered, which confuses an already obfuscated process. In 2010, the National Research Council more carefully describedthe actual criteria that appear to be used, based on the agents on the list currently, and this analysis expanded the considerations to include the ability to produce and disseminate the agent at scale, the publics perception of the microorganism or toxin, and previous reports of bioweapons research on the agent. The Department of Health and Human Services (HHS) has not clarified its official criteria in response.

There is a reason for this lack of transparency: it is the general stance of the US government that the exact deliberations behind an agents inclusion or exclusion is information that, if public, would pose a risk to national security. But obfuscation of how agents become select and a dearth of clear guidelines and metrics for evaluating the effectivenessof the attendant regulations has frustrated many in the scientific community. Some see the list as an obstacle to biosecurity advancements that ultimately leads to negative effects, such as the destruction of invaluable microbial collectionsand the shuttering of important research programs. These effects have stemmed from a variety of restrictions, most notably burdensome transport logistics, reporting rules, and the massive security and safety installation costs necessary to make a laboratory compliant for work with a select agent.

As a first step in addressing whether SARS-CoV-2 deserves select agent status, HHS has presented an interim rule in the Federal Register that seeks to add chimeras combining features of SARS-CoV-1 and SARS-CoV-2 to the select agents list. This is in line with the stance of the government to carefully review and often limit dual-use research of concern, and in particular, gain of function research. However, in our estimation, such chimeric viruses are already regulated by the Code of Federal Regulations, which restricts access to HHS select agents and toxins . . . that have been genetically modified. This newly proposed regulation is therefore duplicative and unnecessary.

The natural next question is: Should SARS-CoV-2 be added to the select agents list? Such a decision seems premature, at best. It is worth noting that the additionof SARS-CoV-1 took nearly a decade, and was a contentiouschoice even then. At the very least, more time is warranted to determine whether SARS-CoV-2 meets the full range of criteria for selection, particularly in regard to whether it could be a desirable candidate for bioweapon development by nefarious actors. Further, the situation begs for the governments reconsideration of the criteria themselves, both stated and presumed. How dynamic do the criteria allow the security community to be in the face of emergent, novel pathogens, which may represent the clearest examples of the select agents of the future? What improvements can be made in the clarity and stringency of such criteria to enhance scientific progress on protective measures without risking national security? And to similar ends, should we establish clearer and more transparent guidelines for future addition and removal of listed agents?

Our position is that regulation of an emergent pathogen is not in the best interest of public health during an ongoing pandemic, and we argue against regulation of any material that may play a role in development and promulgation of necessary biological technologies for preparedness and mitigation efforts. To support this position, we have evaluated SARS-CoV-2 using the National Research Council criteria, and from this analysis, can come to some general conclusions, presented in the table below.

Virulence, pathogenicity, or toxicity of the organism; its potential to cause death or serious disease

Yes

Clearly met and is likely to remain a risk for a significant period of time

Availability of treatments such as vaccines or drugs to control the consequences of a release or epidemic

Partial

Will clearly present lower risk in the near future as a result of mass vaccination campaigns, concomitant protection from vaccination and natural infection, other emerging therapeutic approaches, and general public health precautions like isolation and quarantine

Transmissibility of the organism; its potential to cause an uncontrolled epidemic

Partial

Ease of preparing the organism in sufficient quantity and stability for use as a bioterrorism agent; for example, the ability to prepare large quantities of stable microbial spores

-

Relate more specifically to bioterrorism concerns that are difficult to assess currently. It is still too early to determine the possibility of preparing SARS-CoV-2 at scale, and while ease of dissemination would appear to be high due to natural transmission dynamics, considerations that exclude criteria 2 and 3 will similarly temper this as a risk factor

Ease of disseminating the organism in a bioterrorism event to cause mass casualties; for example, by aerosolization

-

Public perception of the organism; its potential to cause societal disruption by mass panic

Partial

Remains a risk factor, but this is likely to wane precipitously in the near term as infections become less severe and common

Known research and development efforts on the organism by national bioweapons programs

-

While some have claimed that SARS-CoV-2 originated in a laboratory, until data is presented to support these claims, we determine this risk to be inapplicable

SARS-CoV-2 appears to soundly fit only one of these seven criteria, and it is too early to determine whether ongoing biomedical research and public health efforts will successfully alleviate the concerns put forth in three others. While there is not a defined threshold for how many criteria an agent must meet to be selected, there are other pathogens that better fit these criteria which are noton the list. As an example, HIV meets criteria 1, 2 (partial), 3, and 7 more than 35 years after its discovery and has still not been designated a select agent. This illustrates that even these expanded criteria fail to encompass all of the factors that go into government decision-making, in large part because they are undisclosed.

Ultimately, the decision about whether SARS-CoV-2 is named a select agent has broad implications for the scientific and policy communities. Regulation in this manner would severely restrict access to clinical and field samples, and would result in a mass destruction and consolidation campaign the likes of which may rival the one ongoingfor polio, which, though not a select agent, is the subject of an $5.1B eradication effort that includes destroying most samples of the virus and restricting others to certain well-secured labs. Such a campaign for SARS-CoV-2 would have economic ramifications that, while perhaps not debilitating for individual laboratories, are clearly burdensome. But more importantly, these burdens would translate to unavoidable losses in research productivity, which may ultimately harm public health security both in the US and globally. In particular, the development of therapeutics and the acquisition of fundamental knowledge about coronavirus biology could be hobbled.

These concerns are echoes of the past; the scientific community has voiced them before, when SARS-CoV was under consideration for addition to the select agents list. As a biosecurity community, we must seriously consider whether the decision to make SARS-CoV a select agent was connected to, and partly responsible for, the worlds vulnerability to SARS-CoV-2. If we are honest with ourselves about the likelihood that it was, we should take pause at the prospect of similar, rippling regulatory ramifications this time around.


See the rest here: Opinion: Coronavirus and Regulating Access to High-Risk Pathogens - The Scientist
3 more Mainers have died and another 1,115 coronavirus cases reported across the state – Bangor Daily News

3 more Mainers have died and another 1,115 coronavirus cases reported across the state – Bangor Daily News

February 11, 2022

Threemore Mainers have died and another 1,115coronavirus cases reported across the state, Maine health officials said Thursday.

Thursdays report brings the total number of coronavirus cases in Maine to 184,614,according to the Maine Center for Disease Control and Prevention. Thats up from 183,499 on Wednesday.

Of those, 136,105have been confirmed positive, while 48,509were classified as probable cases, the Maine CDC reported.

Two men and a woman in their 70s and 80s from Penobscot County have succumbed to the virus, bringing the statewide death toll to 1,822.

The number of coronavirus cases diagnosed in the past 14 days statewide is 13,090. This is an estimation of the current number of active cases in the state, as the Maine CDC is no longer tracking recoveries for all patients. Thats down from 13,501 on Wednesday.

The new case rate statewide Thursday was 8.33 cases per 10,000 residents, and the total case rate statewide was 1,379.36.

The most cases have been detected in Mainers younger than 20, while Mainers over 80 years old account for the largest portion of deaths. More cases have been recorded in women and more deaths in men.

So far, 4,081 Mainers have been hospitalized at some point with COVID-19, the illness caused by the new coronavirus. Of those, 308 are currently hospitalized, with 66 in critical care and 26 on a ventilator. Overall, 59 out of 378 critical care beds and 258 out of 328 ventilators are available.

The total statewide hospitalization rate on Thursday was 30.49 patients per 10,000 residents.

Cases have been reported in Androscoggin (18,635), Aroostook (8,752), Cumberland (38,586), Franklin (4,516), Hancock (5,395), Kennebec (17,631), Knox (4,415), Lincoln (3,924), Oxford (8,976), Penobscot (20,732), Piscataquis (2,308), Sagadahoc (3,840), Somerset (7,739), Waldo (4,575), Washington (3,208) and York (31,378) counties. Information about where an additional four cases were reported wasnt immediately available.

An additional 977 vaccine doses were administered in the previous 24 hours. As of Thursday, 980,645 Mainers are fully vaccinated, or about 76.6 percent of eligible Mainers, according to the Maine CDC.

As of Thursday morning, the coronavirus had sickened 77,284,578 people in all 50 states, the District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands and the U.S. Virgin Islands, as well as caused 912,549 deaths, according to the Johns Hopkins University of Medicine.

More articles from the BDN


See the original post here: 3 more Mainers have died and another 1,115 coronavirus cases reported across the state - Bangor Daily News
Under 2,000 COVID-19 cases reported Thursday in Utah; 13 new deaths – fox13now.com

Under 2,000 COVID-19 cases reported Thursday in Utah; 13 new deaths – fox13now.com

February 11, 2022

SALT LAKE CITY Utah reported 1,935 new COVID-19 cases Thursday along with an additional 13 deaths in the state, although one occurred before Jan. 10.

There are currently 650 people in Utah hospitalized with COVID-19.

The rolling 7-day average for positive tests is now at 1,956 per day. The rolling 7-day average for percent positivity of "people over people" is 33.4%. and the rolling 7-day average for percent positivity of "tests over tests" is 19.5%.

Among the new cases, school-aged children accounted for 319 of them, including 155 cases in children ages 5-10, 67 cases in children ages 11-13, and 97 cases in children ages 14-18.

"In the last 28 days, people who are unvaccinated are at 8.6 times greater risk of dying from COVID-19, 4.6 times greater risk of being hospitalized due to COVID-19, and 2.4 times greater risk of testing positive for COVID-19 than vaccinated people," UDOH reports. "Since February 1, 2021, people who are unvaccinated are at 6.5 times greater risk of dying from COVID-19, 4.1 times greater risk of being hospitalized due to COVID-19, and 1.4 times greater risk of testing positive for COVID-19 than vaccinated people."

With 13 additional deaths reported Thursday, Utah's death toll stands at 4,250:


See the rest here: Under 2,000 COVID-19 cases reported Thursday in Utah; 13 new deaths - fox13now.com
Autopsy confirms Kansas woman died of allergic reaction to COVID-19 vaccine – KSHB

Autopsy confirms Kansas woman died of allergic reaction to COVID-19 vaccine – KSHB

February 11, 2022

KANSAS CITY, Mo. Following an investigation by the Kansas Department of Health and Environment into the death of a Kansas woman last year, an autopsy confirms her cause of death was an allergic reaction to the Moderna COVID-19 vaccine.

68-year-old Jeanie M. Evans of Effingham, Kansas, received her vaccine in Jefferson County in March 2021. After receiving the shot, she began to experience anaphylaxis, according to KSHB 41's previous reporting.

"The decedent was a 68 year old female with a medical history of hypertension, environmental allergies, "allergic disorder", and reactive airway disease (not asthma), with previous anaphylactic reaction to albuterol," the autopsy report said.

It then described that, on March 23, 2021, about 15 minutes after receiving her first dose of the vaccine, she began to complain that her airway was becoming blocked.

"EMS was called and arrived on scene where she was noted to have severe respiratory distress with labored breathing and stridor and poor oxygen saturation," the report said.

Evans was then transported to the emergency room. She was pronounced dead on March 24.

"Based on the available case history and autopsy findings, it is my opinion that Jeanie Evans, a 68 year old female, died as a result of anaphylaxis due to COVID-19 vaccine administration," the report concluded.

According to the Centers for Disease Control and Prevention, anaphlaxis after receiving the COVID-19 vaccine is rare, with only five people per one million vaccinated experiencing it.

There have been 7,820 deaths due to COVID-19 infections in Kansas and 906,603 deaths in the U.S., according to the CDC.

We want to hear from you on what resources Kansas City families might benefit from to help us all through the pandemic. If you have five minutes, feel free to fill out this survey to help guide our coverage: KSHB COVID Survey.


See the original post:
Autopsy confirms Kansas woman died of allergic reaction to COVID-19 vaccine - KSHB